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ABL Bio, collaborate with global No.1 CDMO Lonza… to spur development and manufacturing
- Increased efficiency and stability of bispecific antibody manufacturing with diversification of CDMO- Acceleration of clinical preparation is expected with End to End Solution ABL Bio (CEO Sanghoon Lee), a company specializing in bispecific antibody, announced that it has signed a collaboration contract with Lonza (Switzerland), the global No. 1 biopharmaceutical CDMO company, for the development and manufacturing of bispecific antibodies. With Lonza supporting the End-to-End Solution, the two companies will work closely together from the initial DNA stage to IND for ABL Bio pipelines. If GS Xceed®, a unique gene expression technology of Lonza, is applied to ABL Bio's bispecific antibody manufacturing, which has already been proven to have advanced technology with its clinical data and license-out experiences, effective and stable manufacturing of high-quality antibodies can be expected. Jennifer Cannon, Global Head of Mammalian Biologics, Lonza commented “With the biologics pipeline evolving towards more complex protein formats, bi- and multi-specific molecules are a growing part of Lonza’s portfolio. For more than 35 years, our teams have built extensive experience and capabilities in this area, and we are committed to supporting our customers in their unique journey to IND. This collaboration will provide ABL Bio with greater flexibility and speed on the path to commercialization. We look forward to working together to bring this innovative therapeutic antibody candidate one step closer to patients.” Sanghoon Lee, ABL Bio CEO, said "This collaboration with Lonza, the world's No. 1 CDMO company, is another leap forward of ABL Bio to become a global top-tier bio company” and added, “As Lonza’s CDMO service is not limited to bispecific antibodies, ABL Bio will diversify its next-generation pipelines such as ADCs to increase growth potential and lead the antibody field.” Meanwhile, ABL Bio's more than 6 pipelines such as ABL001(VEGFxDLL4), ABL111(Claudin18.2x4-1BB), ABL503(PD-L1x4-1BB), ABL105(HER2x4-1BB), ABL202(ROR1xADC), ABL301(a-synxIGF1R) etc. are under global clinical trial in the US, China, and Korea. Pipelines such as ABL103 (B7-H4x4-1BB) and ABL104 (EGFRx4-1BB) etc. are also under preparation to enter clinical trials. In addition to the number of non-clinical pipelines, including ABL603(Claudin18.2xCD3) and ABL602(CLL1xCD3), are also actively underway.
2023-04-04ablbio
ABL Bio, bispecific antibody immuno-oncology ABL 503’s Korea phase 1 IND was approved
- Phase I clinical trial in the U.S. is on the right track.- With superior safety, advantageous in verifying optimal dose over competitors ABL Bio (CEO Sanghoon Lee), a company specializing in bispecific antibody, announced on the xth that it has got approval from the Ministry of Food and Drug Safety (MFDS) for the phase 1 IND of the bispecific antibody immuno-oncology ABL503. ABL503 will expand the phase 1 clinical trial to Korea which is ongoing at 6 clinical institutions in the United States. Hereafter, ABL Bio will get the additional safety data in monotherapy and determine the recommended dose (RP2D) and optimal target cancer for phase 2 clinical trials through the dose expansion part clinical trial. Both ABL503 and ABL111, which are being jointly developed with NASDAQ-listed I-Mab, are on the right track for their phase 1 clinical trial in the US and are showing good clinical results. Bispecific antibody ABL503, which targets PD-L1 and 4-1BB at the same time, selectively activates T cells only in tumor microenvironments. Since 4-1BB can be activated only in immune cells around cancer cells expressing PD-L1. Therefore, it is possible to minimize the side effects of 4-1BB that shows high hepatotoxicity when used as a monoclonal antibody. This is why ABL503 is drawing attention as a new alternative to the existing treatment, which had therapeutic effects for only 20-30% of patients on licensed immune checkpoint inhibitory anticancer drugs, and did not have a treatment with new mechanism in case of recurrence. In particular, considering the interim results of the ongoing clinical trial, ABL503 has a wide range for drug effect verification compared to competitors of the same target based on excellent safety, which is regarded as advantage compared to competitors. Sanghoon Lee, ABL Bio CEO, said "In 2023, we will announce good interim clinical result of existing pipelines as well as news of new pipeline clinical trial initiations” and added “Since ABL Bio’s pipelines are designed to have differentiation with existing competitors, I’m confident that their value will be fairly evaluated if good clinical results continue to be supported." Meanwhile, along with ABL503(PD-L1x4-1BB), ABL Bio's 7 pipelines such as ABL001(VEGFxDLL4), ABL111(Claudin18.2x4-1BB), ABL105(HER2x4-1BB), ABL202(ROR1 ADC), ABL301(a-synxIGF1R) etc. are on global clinical trial in the US, China and Korea. 3 pipelines, ABL103(B7-H4x4-1BB), ABL104(EGFRx4-1BB), and ABL101(BCMAx4-1BB), are also preparing for clinical entry. In addition to the 10 pipelines, R&D of a number of non-clinical pipelines, including ABL603(Claudin18.2xCD3) and ABL602(CLL1xCD3), are also actively underway.
2023-03-30ablbio
ABL Bio enters the phase 1 expansion part of global clinical trials by applying for phase 1 ...
- US phase I clinical trials dose expansion part started in earnest.- Expect excellent anti-cancer effects and minimized toxic side effects with bispecific antibody of new mechanism. ABL Bio (CEO Sanghoon Lee), a company specializing in bispecific antibody, announced on the 7th that it has applied to the Ministry of Food and Drug Safety (MFDS) for the phase 1 clinical trial IND of the bispecific antibody immuno-oncology ABL503. This is to proceed with the dose expansion part, the next step after the dose escalation part of the phase 1 clinical trial currently ongoing in the United States, about two years after applying for phase 1 clinical trial in the US at the end of 2020. ABL Bio plans to secure additional safety data in solitary therapy and determine recommended phase 2 does (RP2D) and optimal target cancer through dose expansion part clinical trials conducted at Korea clinical institutions with 6 US clinical institutions. ABL503, which is applied with Grabbody-T platform technology, is a bispecific antibody immuno-oncology that targets PD-L1 and 4-1BB at the same time, and is currently under joint development with NASDAQ-listed company I-Mab. Although it cannot be disclosed in detail yet, it is said to be raising expectations as it is showing good results in both efficacy and toxicity in phase 1 clinical trials in the US, which is currently in the part of a dose escalation. 4-1BB, which helps activate T cells, is known to have excellent anticancer effects, but high toxic side effects when administered as a single antibody are pointed out as limitation. However, in the case of ABL503 bispecific antibody, 4-1BB can be activated in immune cells around cancer cells expressing PD-L1, so it is possible to minimize the toxic side effects of 4-1BB through selective T-cell activation only in the tumor microenvironment. ABL Bio Sanghoon Lee CEO said, "The US phase 1 clinical trial of ABL111 with 4-1BB-based Grabbody-T platform technology is also showing good progress," adding, "Starting with ABL503 and ABL111, many of the company's Grabbody-T-based pipelines, including ABL103, will be the center of attention." Through this, we will be able to become a leading company in the field of bisepecific antibody for T-cell engagement," he said. Meanwhile, ABL Bio is developing BBB shuttle platform Grabody-B, which is also applied to ABL301, and various pipelines using it as a new drug for degenerative brain diseases, and is developing many pipelines based on 4-1BB-based Grabbody-T in the field of immuno-oncology. Among them, ABL111 is conducting phase 1 clinical trials in the US and China, and ABL103 is expected to enter phase 1 clinical trials this year.
2023-02-07ablbio
ABL Bio receives near-term milestone for ABL301
- $20 million in near-term milestone inflows upon completion of ABL301 GLP tox study- IND application for the phase 1 clinical trial in U.S. is scheduled in the 4Q of this year September 15, 2022 - ABL Bio Inc (CEO, Sang Hoon Lee), a company specializing in bispecific antibody (BsAb), today announced that $20 million out of $45 million in near-term milestones will be received from SANOFI for ABL301, a bispecific antibody under investigation for Parkinson’s Disease and other potential neurodegenerative diseases. The amount will be paid by SANOFI within 45 days. In January, ABL Bio signed an exclusive collaboration and license out agreement worth a total of $1.06 billion with SANOFI, including $75 million of upfront payments and $45 million of near-term milestones. With this contract, SANOFI had exclusive development and commercialization rights worldwide to ABL301. ABL Bio plans to submit IND for a phase 1 clinical trial to the U.S. FDA in the fourth quarter of this year. In addition to the $20 million inflow this time, the near-term milestone of $25 million will be additionally received according to the development progress of ABL301. Meanwhile, ABL Bio will lead the phase 1 clinical trial of ABL301 and Sanofi will be responsible for further clinical development including the phase 2 clinical trial. “As the preclinical development of ABL301 proceeds well, ABL Bio will receive the near-term milestone. IND application for the phase 1 clinical trial is also being smoothly prepared” said Sang Hoon Lee, CEO of ABL Bio. “Thanks to the strong partnership between the two companies, we will do our best to help patients with neurodegenerative diseases, including Parkinson’s disease, enjoy a better life.” Grabody-B is a blood-brain-barrier (BBB)-shuttle BsAb platform that targets the insulin-like growth factor 1 receptor (IGF1R) to maximize BBB penetration of potential therapies for various CNS-related diseases. Utilizing Grabody-B technology, ABL301 effectively carries the anti-alpha-synuclein antibody across the BBB to enhance potential therapeutic efficacy against Parkinson’s Disease. Meanwhile, ABL Bio develops BBB shuttle platform, Grabody-B and other pipeline programs as potential neurodegenerative diseases treatments. In the immuno-oncology area, pipelines based on Grabody-T and Grabody-I platforms are being developed. ABL503 and ABL111 based on Grabody-T are undergoing phase 1 clinical trials in the U.S. ABL101 and ABL103 are expected to initiate phase 1 clinical trials in 2023. ABL501 utilizing Grabody-I is conducting phase 1 clinical trial in South Korea.
2022-09-15ablbio
ABL Bio to receive 6 million milestone payment for ABL001
- Receive milestone payment from Compass Therapeutics as clinical development progresses- Results of the Phase 1b clinical trial was announced in March 29th… U.S. Phase 2 clinical trial begin in Q3 2022 ABL Bio Inc (CEO, Sang Hoon Lee), a company specializing in bispecific antibody (BsAb), today announced that it will receive $6 million milestone payment from Compass Therapeutics as the clinical development of bispecific antibody ABL001(CTX-009/ES104/NOV1501) has progressed. ABL Bio has issued an invoice to Compass Therapeutics, and is expected to receive the milestone payment within 45 days. Compass Therapeutics (Nasdaq: CMPX) is an American biotech company listed on Nasdaq stock exchange. Compass Therapeutics acquired TRIGR Therapeutics last year and gained global rights to ABL001 (renamed CTX-009) with the exception of South Korean rights. Greater China’s rights were out-licensed to Elpiscience. According to the agreement, ABL Bio is responsible for conducting the Phase 1 clinical trial of ABL001, and Compass Therapeutics will continue further clinical development of the program, including the Phase 2 clinical trial. ABL Bio finished the Phase 1b clinical trial of ABL001 and announced the results of the study in March 29th. The U.S. Phase 2 clinical trial of ABL001 has already received IND approval from the FDA, and dosing of the first patient is expected to take place in Q3 2022. “With the completion of Phase 1b study of ABL001 and the ongoing Phase 2 clinical trials in South Korea and the U.S., ABL Bio secures an additional 6 million dollars. If ABL001 succeeds in commercialization, royalties based on sales can also be expected. In the future, we will improve financial stability through continuous technology transfer and lay the foundation to leap forward as a global biotech company” said Sang Hoon Lee, CEO of ABL Bio. ABL001 is a bispecific antibody that simultaneously blocks Vascular Endothelial Growth Factor A (VEGF-A) and Delta-Like Ligand 4 (DLL4) signaling pathways, which are critical to angiogenesis and tumor vascularization. Compass Therapeutics and Handok are conducting multinational Phase 2 clinical trials for patients with biliary tract cancer in South Korea and the U.S.in China, Elpiscience is conducting Phase 1/2 study in patients with advanced colorectal cancer. Meanwhile, ABL Bio develops BBB shuttling platform, Grabody-B and other pipeline programs including ABL30 1 as potential neurodegenerative diseases treatments. In the immuno-oncology area, pipelines based on Grabody-T and Grabody-I are being developed. ABL503 and ABL111 based on Grabody-T are undergoing phase 1 clinical trials in the U.S. ABL101 and ABL103 are expected to initiate phase 1 clinical trials in 2023. ABL501 utilizing Grabody-I is conducting phase 1 clinical trial in South Korea.
2022-06-27ablbio
ABL Bio Enters Global Collaboration and License Agreement with SANOFI to Advance ABL301 for ...
- ABL and SANOFI to collaborate on the development of ABL301, a potential first-in-class bispecific antibody targeting alpha-synuclein and containing a proprietary brain shuttle, for alpha-synucleinopathies, including Parkinson’s disease- ABL301 uses ABL’s Grabody-B platform technology to effectively cross the blood-brain barrier- ABL to receive $75M upfront and up to $985M in potential milestone payments for exclusive global license to ABL301 January 11, 2022, SEONGNAM, South Korea - ABL Bio, Inc. (KOSDAQ: 298380), a clinical-stage biotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, today announced an exclusive collaboration and worldwide license agreement with SANOFI to develop and commercialize ABL301, a pre-clinical stage bispecific antibody targeting alpha-synuclein and IGF1R to treat Parkinson’s disease and other potential indications with enhanced blood-brain barrier (BBB) penetration. Under the terms of the agreement, ABL will receive $75 million in upfront payments. In addition, ABL is eligible to receive up to $985 million based on the achievement of predefined development, regulatory and commercialization milestones, including $45 million in near-term milestones. ABL is also eligible to receive royalties on net sales if the product from the collaboration is commercialized. The transaction will become effective after customary closing conditions are met, such as the HSR clearance. SANOFI will receive worldwide exclusive development and commercialization rights to ABL301. Meanwhile, ABL will lead the preclinical development and Phase 1 clinical trial of ABL301. Thereafter, SANOFI will be responsible for further clinical development, regulatory approval and commercialization of ABL301 worldwide. Grabody-B is a BBB shuttling platform that targets the insulin-like growth factor 1 receptor (IGF1R) to maximize BBB penetration of potential therapies for various CNS-related diseases. Utilizing Grabody-B technology, ABL301 effectively carries the anti-alpha-synuclein antibody across the BBB to enhance therapeutic efficacy against Parkinson’s disease. “This groundbreaking partnership with SANOFI proves the immense possibilities of ABL’s innovative bispecific antibody technology” said Sang Hoon Lee, PhD, CEO of ABL Bio. “We will continue to develop our Grabody-B platform and expand its applicability in other neurodegenerative diseases, such as Alzheimer’s, to contribute to improving the lives of patients worldwide.” About ABL301ABL301 is a bispecific antibody composed of an anti-alpha-synuclein antibody and Grabody-B, a BBB-penetrating shuttle targeting insulin-like growth factor 1 receptor (IGF1R). It is being developed as a potential first-in-class bispecific antibody therapeutics for the treatment of synucleinopathies, including Parkinson’s disease. In preclinical studies, ABL301’s anti-alpha-synuclein domain showed robust recognition of pathological aggregates with high affinity and with minimal affinity to monomeric alpha-synuclein. By utilizing the Grabody-B platform, ABL301 is proven to enter the brains and cerebrospinal fluid (CSF) of rodents and non-human primates more efficiently than an alpha-synuclein monoclonal antibody. Due to its superior BBB-penetrating capability, ABL301 showed better efficacy to reduce brain aggregated alpha-synuclein in a Parkinson’s disease mouse model than the monoclonal alpha- synuclein binding antibody. About Grabody-BLow brain exposure has been one of the major obstacles to the development of central nervous system (CNS) drugs. Grabody-B is a molecular shuttle to facilitate the CNS-penetration of therapeutics through straightforward generation of a bispecific antibody or antibody-drug conjugate. Grabody-B is a non-neutralizing anti-IGF1R antibody and therefore does not interfere with IGF1R signaling nor seriously affect the body’s innate IGF1R axis. Grabody-B has proven to induce significantly higher BBB-penetration of various therapeutic antibodies in rodents and non-human primates with superior efficacy or pharmacodynamic effects compared to monoclonal antibodies. Given IGF1R’s relatively specific expression in the CNS and its non-neutralizing property, Grabody-B is believed to be a safe and efficient shuttle to enhance the efficacy of therapeutics for various CNS-related diseases in clinics. About ABL BioABL Bio, Inc. (KOSDAQ: 298380) is a clinical-stage biotechnology company developing antibody therapeutics for immune-oncology and neurodegenerative diseases. With internal R&D and global partnerships, ABL has developed multiple BsAb platforms, such as ‘Grabody-T,’ ‘Grabody-I’ and ‘Grabody-B’ and built an innovative pipeline of multiple clinical and pre-clinical stage drug candidates. In the oncology area, we have developed Grabody-T, a modular 4-1BB engaging platform that has demonstrated superior efficacy and safety. In the neurodegenerative disorder space, we have developed Grabody-B, which is designed to maximize blood-brain barrier (BBB) penetration. Grabody-B is applicable to various CNS targets across a plethora of neurological disorders, potentially providing a breakthrough to address the high unmet medical needs in neurodegeneration. For more information, please visit www.ablbio.com
2022-01-12ablbio
ABL Bio to Present ABL602 Data at the 63rd ASH Annual Meeting
- ABL602 is a CLL-1/CD3 bispecific antibody for acute myeloid leukemia- Preclinical data highlight potential of ABL602 as a new treatment for AML November 5, 2021, SEONGNAM - ABL Bio, Inc. (KOSDAQ: 298380), a clinical-stage biotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, today announced that new preclinical data for its ABL602, a T-cell engager bispecific antibody targeting CLL-1 and CD3 to treat acute myeloid leukemia (AML), will be presented at the 63rd American Society of Hematology (ASH) Annual Meeting, taking place both online and offline from December 11-14, 2021. “As part of our aim to apply our innovative bispecific antibody technology to a wide range of indications, we are striving to expand our portfolio of blood cancer therapeutics,” said Sang Hoon Lee, PhD, CEO of ABL Bio. “We look forward to participating in the 2021 ASH annual meeting, which will be the first time we showcase ABL602 to a global audience.” Details of the accepted abstract are as follows: Title: A Novel Asymmetrical Anti-CLL-1 x CD3 Bispecific Antibody, ABL602, Induces Potent CLL1-Specific Antitumor Activity with Minimized Sensitization of Pro-Inflammatory CytokinesAbstract Number: 145274Session Title: Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster IIDate & Time: 6:00 PM – 8:00 PM, Sunday, December 12, 2021 About ABL BioABL Bio, Inc. (KOSDAQ: 298380) is a clinical-stage biotechnology company developing antibody therapeutics for immune-oncology and neurodegenerative diseases. With internal R&D and global partnerships, ABL has developed multiple BsAb platforms, such as ‘Grabody-T,’ ‘Grabody-I’ and ‘Grabody-B’ and built an innovative pipeline of multiple clinical and pre-clinical stage drug candidates. In the oncology area, we have developed Grabody-T, a modular 4-1BB engaging platform that has demonstrated superior efficacy and safety. In the neurodegenerative disorder space, we have developed Grabody-B, which is designed to maximize blood-brain barrier(BBB) penetration. Grabody-B is applicable to various CNS targets across a plethora of neurological disorders, potentially providing a breakthrough to address the high unmet medical needs in neurodegeneration. For more information, please visit www.ablbio.com ABL ContactsInvestor InquiriesHyunjun Kiminvestor.relations@ablbio.com+82 31 8018 9845Media InquiriesHee Jun Parkmedia.relations@ablbio.com+82 31 8014 7032
2021-11-05ablbio
[Korea Times] ABL Bio leading Korea's new drug development
https://www.koreatimes.co.kr/www/tech/2021/09/693_316203.html?RD
2021-09-29ablbio
ABL Bio Receives IND Approval for Phase 1 Clinical Trial of ABL501, an anti-LAG-3/PD-L1 Bisp...
- South Korea’s MFDS clears IND application for a Phase 1 study evaluating the safety and preliminary efficacy of ABL501 as a monotherapy for solid tumor treatment- ABL’s third IND this year for bispecific antibody therapeutics August 4, 2021, SEONGNAM, South Korea - ABL Bio, Inc. (KOSDAQ: 298380), a clinical-stage biotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, today announced that the Investigational New Drug (IND) application for ABL501 has been approved by South Korea’s Ministry of Food and Drug Safety (MFDS). The Phase 1 clinical trial is an open-label, multi-center dose escalation and dose expansion study designed to evaluate the safety, tolerability, maximum tolerated dose (MTD) and preliminary efficacy of ABL501 in patients with advanced or metastatic solid tumors. ABL501 uses Grabody-I platform technology to simultaneously block PD-L1 and LAG-3-mediated T cell inhibition. Preclinical results demonstrate a synergistic increase of T cell activation that is higher than the enhancements induced by combination of anti-PD-L1 and LAG-3. ABL501 also showed a good safety profile in monkeys. “LAG-3 is emerging as a promising target for cancer immunotherapy. We look forward to verifying ABL501’s potential as a best-in-class bispecific antibody that overcomes the limitations of current LAG-3 targeting antibodies,” said Sang Hoon Lee, Ph.D., CEO of ABL Bio. “This is already our third IND approval this year, demonstrating our strong commitment to building a robust portfolio of bispecific antibody immunotherapies. Carrying on this momentum, we expect to submit multiple additional INDs next year.” About ABL BioABL Bio, Inc. (KOSDAQ: 298380) is a clinical-stage biotechnology company developing antibody therapeutics for immune-oncology and neurodegenerative diseases. With internal R&D and global partnerships, ABL has developed multiple BsAb platforms, such as ‘Grabody-T,’ ‘Grabody-I’ and ‘Grabody-B’ and built an innovative pipeline of multiple clinical and pre-clinical stage drug candidates. In the oncology area, we have developed Grabody-T, a modular 4-1BB engaging platform that has demonstrated superior efficacy and safety. In the neurodegenerative disorder space, we have developed Grabody-B, which is designed to maximize blood-brain barrier(BBB) penetration. Grabody-B is applicable to various CNS targets across a plethora of neurological disorders, potentially providing a breakthrough to address the high unmet medical needs in neurodegeneration. For more information, please visit www.ablbio.com ABL ContactsInvestor InquiriesHyunjun Kiminvestor.relations@ablbio.com+82 31 8018 9845 Media InquiriesHee Jun Parkmedia.relations@ablbio.com+82 31 8014 7032
2021-08-04ablbio